UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017953 |
|---|---|
| Receipt number | R000020805 |
| Scientific Title | New assessment of therapeutic response to sorafenib for advanced hepatocellular carcinoma |
| Date of disclosure of the study information | 2015/06/19 |
| Last modified on | 2017/06/20 05:22:07 |
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Basic information
Public title
New assessment of therapeutic response to sorafenib for advanced hepatocellular carcinoma
Acronym
New assessment of therapeutic response to sorafenib for advanced hepatocellular carcinoma
Scientific Title
New assessment of therapeutic response to sorafenib for advanced hepatocellular carcinoma
Scientific Title:Acronym
New assessment of therapeutic response to sorafenib for advanced hepatocellular carcinoma
Region
| Japan |
Condition
Condition
hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Although sorafenib has been shown to have significant survival advantages in patients with HCC, RECIST 1.1 may underestimate the efficacy because of modest tumor shrinkage. The aim of this study was to establish an objective radiological evaluation method for anti-tumor response of sorafenib with regard to survival, using LMS, an automated software to measure lesion size, volume and Hounsfield unit (HU) density.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Child-Pugh class A
2) Barcelona Clinic Liver Cancer stage C
3) ECOG performance status 0 or 1
Key exclusion criteria
No follow-up CT images are available
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasunori Kawaguchi |
Organization
Saga-Ken Medical Centre Koseikan
Division name
Department of Hepatobiliary and Pancreatology
Zip code
Address
400 Nakabaru. Kase-machi, Saga-shi, Saga 840-8571, Japan
TEL
0952-24-2171
kawaguy222@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasunori Kawaguchi |
Organization
Saga-Ken Medical Centre Koseikan
Division name
Department of Hepatobiliary and Pancreatology
Zip code
Address
400 Nakabaru. Kase-machi, Saga-shi, Saga 840-8571, Japan
TEL
0952-24-2171
Homepage URL
kawaguy222@gmail.com
Sponsor or person
Institute
Saga-Ken Medical Centre Koseikan
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Canon Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 19 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2014 | Year | 09 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective study: Exploring of new imaging biomarkers for survival among the patients under sorafenib treatment since it was commercially available in 2008. Follow-up CT scans were taken every 2-3 mo for evaluation. Such biomarkers may include longest diameter, lesion volume and HU density.
Prospective study: Based on the best results of retrospective study, prediction/classification ability for survival will be validated by supporting physicians' medication decision on sorafenib. Follow-up CT scans will be taken every 2-3 mo for evaluation.
Management information
Registered date
| 2015 | Year | 06 | Month | 17 | Day |
Last modified on
| 2017 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020805
